Walking Capacity in Parkinson's Disease (PD-Walk)

This study has suspended participant recruitment.
(20 subjects completed for a pilot, further funding required to continue study)
Sponsor:
Collaborator:
South West Sydney Local Health District
Information provided by:
University of Sydney
ClinicalTrials.gov Identifier:
NCT00261781
First received: December 1, 2005
Last updated: July 1, 2008
Last verified: June 2008
  Purpose

The major aim of this study is to determine the efficacy of a home-based treadmill walking program in improving walking capacity and quality of life in people with early mid-stage Parkinson's disease(PD).


Condition Intervention Phase
Idiopathic Parkinson's Disease
Behavioral: Treadmill training
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Does Home-Based Treadmill Training Improve Walking Capacity and Quality of Life in People With Early to Mid-Stage Parkinson's Disease?

Resource links provided by NLM:


Further study details as provided by University of Sydney:

Primary Outcome Measures:
  • Distance walked in 6 minutes [ Time Frame: study entry (0 weeks), 7 and 13 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Unified Parkinson's disease Rating Scale (UPDRS) - motor examination [ Time Frame: 0, 7 and 13 weeks ] [ Designated as safety issue: No ]
  • The Parkinson's disease Questionnaire (PDQ-39 [ Time Frame: 0, 7 and 13 weeks ] [ Designated as safety issue: No ]
  • Walking Automaticity, determined as the velocity of walking 10m while performing a concurrent (cognitive or cognitive + physical) task expressed as a percentage of the velocity of walking 10m without performing the concurrent task. [ Time Frame: 0, 7 and 13 weeks ] [ Designated as safety issue: No ]
  • Walking consistency determined as the co-efficients of variation for stride time and stride length recorded during the 6 minute walk test. [ Time Frame: 0, 7 and 13 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 140
Study Start Date: May 2005
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Treadmill training
    Walking on a treadmill 3 times per week for 6 weeks
Detailed Description:

After Alzheimer's disease, Parkinson's disease (PD) is the most common degenerative neurological condition suffered by Australians, with more than 30,000 Australians having PD at any one time (Parkinson's Australia). Hypokinesia, ie, reduced speed and amplitude of movement, is a major impairment of motor control affecting walking in people with PD. Over time, the development of slow, shuffling walking contributes to loss of independence and falls, with devastating consequences for individuals with PD and their families(Ashburn et al, 2001, Playfer 2001). Any decrease or delay in disability will reduce the personal and financial costs to individuals with PD, their families, health care resources and the community.

A number of previous studies suggest exercise capacity and exercise habits are positively correlated. In people with mild Parkinson's disease (Canning et al 2005), walking capacity, measured as distance walked in the 6-min walk test, correlated with the amount of walking (r=.64, p<0.01) performed each week. Similarly, in an earlier study of people with mild to moderate Parkinson's disease, regular exercise was associated with better exercise capacity (Canning et al 1997). It appears, therefore, that proactive intervention aimed at developing good exercise habits in sedentary individuals with early to mid-stage Parkinson's disease has the potential to reduce or delay walking difficulties.

This study aims to establish the efficacy of a home-based treadmill walking program in providing an early intervention which addresses the primary motor control impairment of hypokinesia, while at the same time maintaining or improving exercise capacity.

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • clinical diagnosis of idiopathic Parkinson's disease
  • aged 30-80 years old
  • subjective disturbance of gait and / or Unified Parkinson's disease rating scale (UPDRS) gait subscore of 1
  • sedentary, defined as performing less than 2 hours / week of leisure-time physical activity over the prior 3 months
  • have adapted to their current anti-Parkinsonian medication for at least 2 weeks

Exclusion Criteria:

  • motor fluctuations or dyskinesias which are disabling
  • require the use of a walking aid
  • more than one fall in the last 12 months
  • Mini-Mental State Examination score of <24
  • exhibit other neurological or musculoskeletal conditions affecting walking
  • chest pain at rest or during exercise in the last 3 months, or heart attack, angioplasty or heart surgery in the last 6 months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00261781

Locations
Australia, New South Wales
Westmead Hospital
Sydney, New South Wales, Australia, 2145
Sponsors and Collaborators
University of Sydney
South West Sydney Local Health District
Investigators
Principal Investigator: Colleen G Canning, PhD University of Sydney
  More Information

Publications:
Responsible Party: Dr Colleen Canning, The University of Sydney
ClinicalTrials.gov Identifier: NCT00261781     History of Changes
Other Study ID Numbers: U3189
Study First Received: December 1, 2005
Last Updated: July 1, 2008
Health Authority: Australia: National Health and Medical Research Council

Keywords provided by University of Sydney:
Treadmill
Walking
Exercise
Automaticity
Quality of Life

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on April 20, 2014